Z-0288-2024 Class II Ongoing
FDA device recall Z-0288-2024 was initiated by Olympus Corporation of the Americas on October 2, 2023 and is designated Class II. Reason for recall: Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel. The recall status is ongoing. Affected quantity: 1687 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 15, 2023
- Initiation Date
- October 2, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1687 units
Product Description
EVIS EXERA III Gastrointestinal Videoscope
Reason for Recall
Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
Distribution Pattern
Nationwide Distribution.
Code Information
Model No. GIF-1TH190; UDI-DI: 04953170343360; All Serial Numbers.